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METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

Primary Purpose

Chronic Ischemic Heart Disease

Status

Terminated

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

intramyocardial injection of BM cells

intramyocardial / intracoronary injection of BM cells

Best medical therapy

About this trial

This is an interventional treatment trial for Chronic Ischemic Heart Disease focused on measuring LVEF < 40%

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic cardiac ischemic disease at least 4 months after one ore more myocardial infarctions in a stable phase of the disease without option for revascularization
LVEF at echocardiography ≤ 40%
Significant regional LV wall motion dysfunction in the infarct related territory
Symptoms NYHA II-IV or CCS II-III (at least class III according to one of the two classifications)
Patient agrees to comply with all follow-up evaluations
Age > 18 years old
Patient has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent

Exclusion Criteria:

Abnormal regional wall motion outside the infarct region
Need for revascularization in a non infarct-related coronary within 6 months
Patient has moderate to severe aortic valve disease, aortic or mitral prosthetic valve
Patient has a significant mitral valve insufficiency (Effective Regurgitant office - ERO - > 0.2 cm2 with possibility of mitral valve surgery
Left ventricular thrombus at echocardiography
LV-aneurysma planned surgical aneurysmectomy
LV-wall thickness < 5mm in the target territory
Congenital heart disorder of hemodynamic relevance
Known active infection or chronic infection with HIV, HBV or HCV
Chronic inflammatory disease
Serious concomitant disease with a life expectancy of less than one year
Follow up impossible (no fixed abode, etc)
Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia)
Severe renal failure (creatinine > 250 mmol/l)
Relevant liver disease (GOT > 2x norm or spontaneous INR > 1,5)
Anemia (Hb < 8.5 mg/dl), Thrombocytopenia (< 100.000/µl)
Women of child bearing potential or pregnancy
Participation at a clinical trial in the last 30 days

Sites / Locations

Cardiocentro Ticino

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Intramyocardial injection of BM cells

Intramyocardial / intracoronary injection of BM cells

control

Arm Description

Outcomes

Primary Outcome Measures

Troponin samples

Measurements of Troponine after cell injection

Number of patients with adverse events at short term

Number of patients with adverse events at mid/long term

Secondary Outcome Measures

change in LVEF

First 10 patients + following randomization phase (n = 54); assessment of short term safety (1 week), Adverse events within 1 year; efficacy measurements 6 months after treatment

change in Quality of life

change in Vo2 max

change in functional status (Vo2 max)

Full Information

NCT ID

NCT01666132

First Posted

June 27, 2011

Last Updated

August 19, 2015

Sponsor

Cardiocentro Ticino

1. Study Identification

Unique Protocol Identification Number

NCT01666132

Brief Title

METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

Official Title

METHOD - Phase I/II Study of Intramyocardial Injection of Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

Due to the slow recruitment process and the progress of newer cell types we decided to stop the trial after the phase 1 (after 10 patients included)

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cardiocentro Ticino

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Intramyocardial, NOGA guided injection of bone marrow derived mononuclear cells in patients with chronic ischemic heart disease and LVEF < 40%. The primary objective is to determine whether the administration of the cells improves recovery of the left ventricular function. Secondary objective is the finding of clinical or paraclinical parameters to predict potential benefits of the treatment (basing on MRI characteristics such as size, transmurality of the myocardial infarction and peri-lesional ischemia). In the first part of the study 10 patients are treated without control group. This phase serves as feasibility and safety part of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Ischemic Heart Disease

Keywords

LVEF < 40%

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intramyocardial injection of BM cells

Arm Type

Experimental

Arm Title

Intramyocardial / intracoronary injection of BM cells

Arm Type

Experimental

Arm Title

control

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

intramyocardial injection of BM cells

Intervention Description

only intramyocardial, NOGA guided injection on BM cells.

Intervention Type

Other

Intervention Name(s)

intramyocardial / intracoronary injection of BM cells

Intervention Description

combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells

Intervention Type

Other

Intervention Name(s)

Best medical therapy

Intervention Description

initially no intervention; crossover to therapy 6 months after enrollment

Primary Outcome Measure Information:

Title

Troponin samples

Description

Measurements of Troponine after cell injection

Time Frame

1 day after cell injection

Title

Number of patients with adverse events at short term

Time Frame

within 1 week after cell injection

Title

Number of patients with adverse events at mid/long term

Time Frame

up to 12 months after cell injection

Secondary Outcome Measure Information:

Title

change in LVEF

Description

First 10 patients + following randomization phase (n = 54); assessment of short term safety (1 week), Adverse events within 1 year; efficacy measurements 6 months after treatment

Time Frame

6 months vs. baseline

Title

change in Quality of life

Time Frame

6 months vs. baseline

Title

change in Vo2 max

Description

change in functional status (Vo2 max)

Time Frame

6 months vs. bl

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic cardiac ischemic disease at least 4 months after one ore more myocardial infarctions in a stable phase of the disease without option for revascularization LVEF at echocardiography ≤ 40% Significant regional LV wall motion dysfunction in the infarct related territory Symptoms NYHA II-IV or CCS II-III (at least class III according to one of the two classifications) Patient agrees to comply with all follow-up evaluations Age > 18 years old Patient has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent Exclusion Criteria: Abnormal regional wall motion outside the infarct region Need for revascularization in a non infarct-related coronary within 6 months Patient has moderate to severe aortic valve disease, aortic or mitral prosthetic valve Patient has a significant mitral valve insufficiency (Effective Regurgitant office - ERO - > 0.2 cm2 with possibility of mitral valve surgery Left ventricular thrombus at echocardiography LV-aneurysma planned surgical aneurysmectomy LV-wall thickness < 5mm in the target territory Congenital heart disorder of hemodynamic relevance Known active infection or chronic infection with HIV, HBV or HCV Chronic inflammatory disease Serious concomitant disease with a life expectancy of less than one year Follow up impossible (no fixed abode, etc) Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia) Severe renal failure (creatinine > 250 mmol/l) Relevant liver disease (GOT > 2x norm or spontaneous INR > 1,5) Anemia (Hb < 8.5 mg/dl), Thrombocytopenia (< 100.000/µl) Women of child bearing potential or pregnancy Participation at a clinical trial in the last 30 days

Facility Information:

Facility Name

Cardiocentro Ticino

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

29600778

Citation

Maffessanti F, Prinzen FW, Conte G, Regoli F, Caputo ML, Suerder D, Moccetti T, Faletra F, Krause R, Auricchio A. Integrated Assessment of Left Ventricular Electrical Activation and Myocardial Strain Mapping in Heart Failure Patients: A Holistic Diagnostic Approach for Endocardial Cardiac Resynchronization Therapy, Ablation of Ventricular Tachycardia, and Biological Therapy. JACC Clin Electrophysiol. 2018 Jan;4(1):138-146. doi: 10.1016/j.jacep.2017.08.011. Epub 2017 Nov 6.

Results Reference

derived

PubMed Identifier

23720276

Citation

Surder D, Radrizzani M, Turchetto L, Cicero VL, Soncin S, Muzzarelli S, Auricchio A, Moccetti T. Combined delivery of bone marrow-derived mononuclear cells in chronic ischemic heart disease: rationale and study design. Clin Cardiol. 2013 Aug;36(8):435-41. doi: 10.1002/clc.22148. Epub 2013 May 29.

Results Reference

derived

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METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic Disease

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